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Outcomes of Neonatal Acute Kidney Injury In Premature Infants

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ClinicalTrials.gov Identifier: NCT02375854
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Mamta Fuloria, Montefiore Medical Center

Brief Summary:
The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to a comprehensive clinical database.

Condition or disease Intervention/treatment
Acute Kidney Injury Chronic Kidney Disease Other: Observation

Detailed Description:
This is an observational pilot study to enhance understanding of the pathophysiology and epidemiology associated with effects of AKI in premature infants and the role that neonatal AKI plays in future development of CKD. In eligible preterm infants, blood and urine samples will be collected at pre-specified time points during hospitalization and at outpatient follow-up appointments at 6 months, 1 year, 2 years, and 5 years of age and stored in the biorepository. Blood pressure will be measured and recorded at NICU discharge and at all follow-up visits. A renal ultrasound will be performed to monitor renal growth at 2 and 5 years of age. All data will be entered into a comprehensive clinical database, including laboratory results.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Outcomes of Neonatal Acute Kidney Injury and Prematurity: An Observational Study and Einstein-Montefiore Neonatal Acute Kidney Injury Clinical Registry and Biorepository
Study Start Date : November 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
Preterm infants
Less than 32 weeks' gestation
Other: Observation



Primary Outcome Measures :
  1. Chronic kidney disease (incidence of chronic renal insufficiency in childhood) [ Time Frame: 5 years ]
    Determine the incidence of chronic renal insufficiency in childhood


Secondary Outcome Measures :
  1. Acute kidney injury (incidence of acute kidney injury in preterm infants) [ Time Frame: 0-5 months ]
    Determine the incidence of acute kidney injury in preterm infants

  2. Assessment of serum biomarkers - cystatin C [ Time Frame: 0 months - 5 years ]
    Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency

  3. Assessment of urinary biomarkers - urinary neutrophil gelatinase-associated lipocalin, interlukin 18 and kidney-injury molecule-1 [ Time Frame: 0 months - 5 years ]
    Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency


Biospecimen Retention:   Samples Without DNA
Blood and urine samples


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Preterm infants less than 32 weeks' gestational age
Criteria

Inclusion Criteria:

  • Preterm infants less than 32 weeks/ gestational age admitted to the Neonatal Intensive Care Unit at Weiler Hospital (The Children's Hospital at Montefiore).

Exclusion Criteria:

  • Known major congenital anomalies of the kidney and urinary tract (CAKUT) including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal hypoplasia, obstructive uropathy
  • Other genetic syndromes or medical conditions that preclude enrollment per judgment of the attending neonatologist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375854


Contacts
Contact: Mamta Fuloria, MD 718-904-4105 mfuloria@montefiore.org
Contact: Deborah Campbell, MD 718-904-4105 dcampbel@montefiore.org

Locations
United States, New York
Jack D. Weiler Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Mamta Fuloria, MD    718-904-4105    mfuloria@montefiore.org   
Contact: Deborah Campbell, MD    718-904-4105    dcampbel@montefiore.org   
Sub-Investigator: Kimberly Reid, MD         
Sub-Investigator: Rani Thekumparampil, MD         
Sub-Investigator: Frederick Kaskel, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Mamta Fuloria, MD The Children's Hospital at Montefiore, Albert Einstein College of Medicine

Responsible Party: Mamta Fuloria, Assistant Professor, Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02375854     History of Changes
Other Study ID Numbers: 2013-2900
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Mamta Fuloria, Montefiore Medical Center:
preterm
acute kidney injury
biomarkers
chronic kidney disease

Additional relevant MeSH terms:
Wounds and Injuries
Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency